MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MAGELLAN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850215
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported an issue regarding the use of the safety needle and stated "ampule bags/pfs/vial leaks." the product information was not provided.
Additional Manufacturer Narrative
Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The customer reported an issue regarding the use of the safety needle and stated "ampule bags/pfs/vial leaks".On 09jun2024 the customer provided additional information stating that liquid leaked out on the side.
Additional Manufacturer Narrative
Additional event information was received from the customer on 09jun2024 therefore sections b5, d1 and d4 were updated.
Additional Manufacturer Narrative
Investigation summary: samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A corrective action is not applicable at this time.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Section d4 unique identifier (udi) # was corrected.
Additional Manufacturer Narrative
The device history record (dhr) for lot 004115 was reviewed and no anomalies related to the reported issue were observed.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.One device was returned for evaluation and the reported issue was observed.However, the investigation did not identify a systemic issue with the product or process.A specific root cause could not be identified based on available information.Therefore, a corrective and preventive action (capa) is not necessary at this time.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: MAGELLAN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18909330
• Report Number: 1017768-2024-00030
• Device Sequence Number: 12455039
• Product Code: FMI
• UDI-Device Identifier: 10884521000087
• UDI-Public: (01)10884521000087(17)241231(10)004115
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K012736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/31/2024
• Device Model Number: 8881850215
• Device Catalogue Number: 8881850215
• Device Lot Number: 004115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/22/2024; Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 03/29/2024; 06/12/2024; 09/04/2024; 10/02/2024; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown